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STP206 for the Prevention of NEC

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Leadiant Biosciences, Inc.
Sponsor:
Information provided by (Responsible Party):
Leadiant Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01954017
First received: September 18, 2013
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
The study will be conducted in two parts. Part A will be a sequential dose escalation study to determine the safety and tolerability of two doses of STP206 versus control. Part B will evaluate safety and NEC preventive efficacy of STP206 in VLBW and ELBW neonates.

Condition Intervention Phase
Necrotizing Enterocolitis
Biological: STP 206
Biological: Sterile Water
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official Title: A Phase Ib/IIa Randomized, Placebo Controlled Study of the Safety and Efficacy of Once Daily Dosing of STP206 in Premature Very Low Birth Weight and Extremely Low Birth Weight Neonates

Resource links provided by NLM:


Further study details as provided by Leadiant Biosciences, Inc.:

Primary Outcome Measures:
  • To assess the safety and tolerability of once daily dosing of two dose levels of STP206 versus control in four different birth weight strata in premature neonates. [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • Assess the fecal shedding after daily dosing of each component of STP206 throughout the dosing phase [ Time Frame: 48 months ]
  • Describe the incidence of NEC in STP206-treated subjects compared to control [ Time Frame: 48 months ]
  • Describe the incidence of clinical events (sepsis/bacteremia, feeding intolerance, morbidity/complications of prematurity) in STP206-treated subjects compared to control [ Time Frame: 48 months ]
  • Describe the progression of standard neonatal growth parameters in STP206-treated subjects compared to control [ Time Frame: 48 months ]

Estimated Enrollment: 400
Study Start Date: December 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: STP 206
Biological
Biological: STP 206
Live Biotherapeutic
Placebo Comparator: Sterile Water
Sterile water
Biological: Sterile Water

  Eligibility

Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B
  2. Ability to start treatment within four days after birth.
  3. Gestational age between 23 and 32 weeks at birth
  4. Obtaining of informed consent from the subject's mother after full understanding of the study purpose and procedures.
  5. Parents who agree to allow the Principal Investigator and his/her staff to follow the procedures and assessments required by the protocol

Exclusion Criteria:

  1. Infants with, or at high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis with the expectation of empirical antimicrobial therapy for ≥5 days)
  2. Infants with persistent pulmonary hypertension of the newborn (PPHN)
  3. Congenital or chromosomal anomalies
  4. Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)
  5. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care)
  6. Other conditions of the infant which, in the opinion of the attending neonatologist, preclude participation
  7. Positive maternal HIV status
  8. Participation in another interventional clinical trial

    For Part A of the study, the following additional exclusion criterion will apply:

  9. Small for gestational age neonates, i.e. neonates that weigh less that the 10th percentile for their gestational age according to the Estimated Fetal Weight Percentile Chart
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954017

Contacts
Contact: Daniel Falleroni 301-670-5447 daniel.falleroni@leadiant.com
Contact: Scott Rodgers, MS, CCRA 301-670-1565 scott.rodgers@leadiant.com

Locations
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Jennifer Querim    860-837-5349    jquerim@connecticutchildrens.orgdrens.org   
Contact: Kim Jennings    860-837-5874    kjennings@connecticutchildrens.org   
Principal Investigator: Leslie Wolkoff, MD         
United States, Florida
Sheridan Clinical Research / Plantation General Hospital Recruiting
Sunrise, Florida, United States, 33323
Contact: James Pillitteri    954-592-8218    James.Pillitteri@shcr.com   
Principal Investigator: Mitchell Stern, MD         
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30909
Contact: Tanya Mims    706-721-9680    tamims@gru.edu   
Contact: Nancy Starnes    706-721-9680    nstarnes@gru.edu   
Principal Investigator: Jatinder Bhatia, MD         
United States, Illinois
NorthShore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Ilene Sue Wolf, RNC CCRP    847-570-2045    iwolf@northshore.org   
Principal Investigator: Brandy L Frost, MD         
Southern Illinois University School of Medicine Recruiting
Springfield, Illinois, United States, 62769
Contact: Allison Spenner    217-545-9714    aspenner@siumed.edu   
Contact: Carol Peterson    217-545-5061    cpeterson@siumed.edu   
Principal Investigator: Beau Batton, MD         
United States, Kansas
Wesley Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Paula Delmore, MSN    316-962-8555      
Principal Investigator: Barry T Bloom, MD         
United States, Kentucky
University of Louisville Withdrawn
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Neha Thakkar    617-667-8776    npthakka@bidmc.harvard.edu   
Principal Investigator: Ivan Frantz, MD         
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Deborah Klein    413-599-0226    deborah.klein@baystatehealth.org   
Principal Investigator: Rachana Singh, MD         
United States, North Carolina
WakeMed Health and Hospitals Recruiting
Raleigh, North Carolina, United States, 27610
Contact: Ginger Rhodes-Ryan, MSN, NNP-BC    919-350-7026    grhodes-ryan@wakemed.org   
Principal Investigator: Stephen Kicklighter, MD         
United States, South Carolina
Medical University South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kenreka Yeardon    843-876-1471    yeardon@musc.com   
Principal Investigator: Sarah Taylor, MD         
United States, Tennessee
University of Tennessee Recruiting
Memphis, Tennessee, United States, 38163
Contact: Sandra Jean Grimes    901-448-1823    sgrimes@uthsc.edu   
Principal Investigator: Ramasubbareddy Dhanireddy, MD         
United States, Texas
The Medical Center of Plano Recruiting
Plano, Texas, United States, 75075
Contact: Melanie Kelly    954-838-2479    Melanie.Kelly@shcr.com   
Principal Investigator: Jenitha Jeyaraj, MD         
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Susan Collins, RN    304-293-7348    scollins@hsc.wvu.edu   
Principal Investigator: Autumn Kiefer, MD         
Sponsors and Collaborators
Leadiant Biosciences, Inc.
Investigators
Principal Investigator: Michael S Caplan, MD NorthShore University HealthSystem
  More Information

Responsible Party: Leadiant Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01954017     History of Changes
Other Study ID Numbers: STP206-002
Study First Received: September 18, 2013
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Enterocolitis, Necrotizing
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on March 22, 2017